MDACC Study Summary 2009-0501

Study Summary
No. 2009-0501:.......Lung......Cindy L. Carmack......Behavioral Science

Study Summary Title



Study Summary Number:	2009-0501

Study Title:	Evaluating Interactive Cancer Communication Systems in Lung Cancer

Physician

New Patient Referral



Name:	Cindy L. Carmack	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3582 Contact us about clinical trials

General Information



Disease Group:	Lung	Supported By:	National Cancer Institute

Phase of Study:	N/A	Return Visit:	No visits are required as this psychosocial intervention is delivered over the Internet, which participants may access from their homes.

Treatment Agents:	Behavioral intervention	Home Care:	Participants will access their assigned study conditions on the Internet using either their own home computer or one provided to them by the study.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this research study is to learn if people with lung cancer can benefit from using a website called the CHESS-LC (Comprehensive Health Enhancement Support System - Lung Cancer). Researchers want to learn if the CHESS-LC can change quality of life and length of survival in people with lung cancer.

Study Objectives / Outcomes

The major aim of this proposed research is to examine whether patient quality of life and length of survival is impacted by the CHESS-LC (Comprehensive Health Enhancement Support System - Lung Cancer) intervention. To accomplish this, we will conduct a longitudinal, randomized clinical trial comparing the CHESS-LC intervention to an Internet Control group. The primary aims and related hypotheses are:
1) Determine the impact of CHESS-LC on patient quality of life. We hypothesize that at 6 and 12 months posttest, quality of life will be greater among CHESS-LC users compared to the control group.
2) Determine the impact of CHESS-LC on patient survival. Compared to a Usual Care Control, CHESS-LC patients will have greater median survival.

Self Determination Theory (SDT) provides a framework for the analysis of mechanisms by which CHESS-LC may have a positive impact on quality of life and survival. The secondary aims and hypotheses are:
1) Examine the effects of CHESS-LC use on the SDT constructs of competence, autonomy, and relatedness. We hypothesize that CHESS-LC will enhance autonomy, competence and relatedness.
2) Examine the factors that moderate the effect of CHESS-LC use on SDT constructs. We hypothesize that age, gender, education, stage of cancer, cancer treatment, and co-morbidities may moderate the effect of CHESS-LC use on competence, autonomy, and relatedness.
3) Test whether competence, autonomy and relatedness mediate the effects of CHESS-LC use on QOL as hypothesized.
4) Test whether treatment participation mediates the effect QOL has on survival as hypothesized.
5) Characterize the effects of patient-caregiver relationship quality (relatedness) on patient QOL over time and determine whether this association differs depending on the combined effects of gender (male vs. female) and social role (patient vs. caregiver).

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	01/07/2010

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	826

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients must have a diagnosis of non-small cell lung cancer (Stage IIIA, IIIB or IV)

2) Patients must be within 12 months of their primary lung cancer diagnosis of Stage IIIA, IIIB or IV disease or recurrence

3) Patients and caregivers must be at least 18 years of age

4) Patients must have an ECOG Performance Status rating of level 0, 1, or 2

5) Patients and caregivers must be able to speak and read English (educational attainment of at least 6th grade)

6) Patients must be receiving care from a clinician who has consented to participate in this study

Exclusion Criteria:

1) For patients, unstable brain metastases as indicated by repeat CT scan.

Links

Registration Number: Not Applicable Clinical Trial